A Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants

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The purpose of this study is to evaluate the hemostatic efficacy of andexanet alfa in patients receiving a factor Xa inhibitor who are experiencing an acute major bleed. The safety of andexanet will also be studied.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion:

Acute major bleeding episode requiring urgent reversal of anticoagulation; defined by at least one of the following:

Acute bleeding that is potentially life-threatening, OR

Acute bleeding associated with a fall in hemoglobin level by ≥2 g/dL, OR

Acute bleeding associated with a hemoglobin level of ≤8 g/dL if no baseline hemoglobin is available, OR

Acute bleeding in a critical area or organ such as intraspinal, pericardial, or intracranial.

If bleeding is intracranial or intraspinal, the patient must have undergone a head CT or MRI scan demonstrating the bleeding.

Patient received or is believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin.

For patients with intracranial bleeding, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation.

Exclusion:

The patient is scheduled to undergo surgery in less than 12 hours, with the exception of minimally invasive surgery/procedures.

A patient with an intracerebral hemorrhage has any of the following:

Glasgow coma score < 7, OR

Intracerebral hematoma > 60 cc as assessed by CT or MRI

Patients with visible, musculoskeletal or intra-articular bleeding as their qualifying bleed.